Continence Across Continents to Upend Stigma and Dependency

Quality of Life Clinical Trial

— CACTUS-D  

Official title:

Phase 3 Cluster Randomised Trial Testing the Efficacy of a Continence Promotion Intervention to Improve Urinary Symptoms and Quality of Life, and Reduce Stigma and Falls in Older Community-dwelling Women With Untreated Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858493
• Other study ID #: ERA-AGE2 dossier28835
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: July 20, 2017
• Start date: May 2013
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether women exposed to the continence promotion intervention will report improved urinary symptoms and quality of life, and lower incontinence-related stigma and falls than women who receive a control intervention at one-year post-intervention.

Description:

This is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on:

1. Improved urinary symptoms and quality of life

2. Reduction in falls

3. Reduction in stigma

A cost-effectiveness component will also be included

Recruitment information / eligibility

• Status: Completed
• Enrollment: 910
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Women

• 65 years and older

• Urinary incontinence at least once weekly

Exclusion Criteria:

• Living in residential or long-term care

• Received treatment for incontinence within the past year

• Dementia or other neurological conditions that preclude the ability to provide -Informed consent

Related Conditions & MeSH terms

• Enuresis
• Falls, Accidental
• Quality of Life
• Stigma
• Urinary Incontinence

Intervention

Behavioral:
• Continence promotion group education workshop
Interactive group education workshop promoting continence
• Sham health lecture
Interactive group education workshop about general health

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Institut universitaire de gériatrie de Montréal	Montreal	Quebec
France	Université de Poitiers	Poitiers	Poitou-Charentes
United Kingdom	University of Brunel	Uxbridge	Middlesex

Sponsors (5)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal	Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, Institut national de prevention et d'education pour la sante, Medical Research Council

Countries where clinical trial is conducted

Canada,  France,  United Kingdom, 

References & Publications (2)

Agnew R, van den Heuvel E, Tannenbaum C. Efficiency of using community organisations as catalysts for recruitment to continence promotion trials. Clin Trials. 2013 Feb;10(1):151-9. doi: 10.1177/1740774512460144. Epub 2012 Oct 5. — View Citation

Tannenbaum C, Agnew R, Benedetti A, Thomas D, van den Heuvel E. Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial. BMJ Open. 2013 Dec 10;3(12):e004135. doi: 10.1136/bmjopen-2013-004135. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-utility of the continence promotion intervention	Cost/QALY. Direct costs will include costs related to the intervention as well as health care resource use due to incontinence-associated falls and health care seeking for incontinence will be measured. Indirect costs will be measured such as the time lost from work for a child or spouse to accompany the participant to receive medical treatment for incontinence or falls. The change in utility from the baseline incontinent condition to improved incontinence with increased social participation and decreased stigma on quality of life will be calculated from SF6D utilities derived from the SF-12 questionnaire at baseline and 1-year follow-up. A disease-specific measure, the IQOL is currently undergoing mapping onto the SF-6D to see if it will provide a more responsive indication of improved quality of life than the generic SF-12 measure.	1-year
Primary	Self-reported improvement in urinary incontinence	Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS	1 year
Secondary	Falls	Reduction in incontinence-related falls measured by fall diary	1 year
Secondary	Reduction in incontinence related stigma and quality of life	Measured with the Incontinence Quality of Life questionnaire (IQOL)	1 year